商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | 090040 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE; INJECTION | 2MCG/ML | No | No | 2011/03/15 (TA) | -- | COBREK PHARMA | None (Tentative Approval) |
DOXERCALCIFEROL | 091433 | 001 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 0.5MCG | No | No | 2011/09/23 | 2011/09/23 | HIKMA | Discontinued |
DOXERCALCIFEROL | 091433 | 002 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 1MCG | No | No | 2011/09/23 | 2014/01/14 | HIKMA | Discontinued |
DOXERCALCIFEROL | 091433 | 003 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 2.5MCG | No | No | 2011/09/23 | 2014/01/14 | HIKMA | Discontinued |
DOXERCALCIFEROL | 091101 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2013/08/30 | 2013/08/30 | HIKMA | Prescription |
DOXERCALCIFEROL | 091433 | 001 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 0.5MCG | No | No | 2014/01/14 | 2011/09/23 | HIKMA | Discontinued |
DOXERCALCIFEROL | 091433 | 002 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 1MCG | No | No | 2014/01/14 | 2014/01/14 | HIKMA | Discontinued |
DOXERCALCIFEROL | 091433 | 003 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 2.5MCG | No | No | 2014/01/14 | 2014/01/14 | HIKMA | Discontinued |
DOXERCALCIFEROL | 200926 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2014/02/04 | 2014/02/04 | SANDOZ | Prescription |
DOXERCALCIFEROL | 091333 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2014/05/05 | 2014/05/05 | SANDOZ | Prescription |
DOXERCALCIFEROL | 203929 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2015/05/07 | 2015/05/07 | EPIC PHARMA LLC | Discontinued |
DOXERCALCIFEROL | 203929 | 002 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 2MCG/ML (2MCG/ML) | No | No | 2015/05/07 | 2016/03/28 | EPIC PHARMA LLC | Discontinued |
DOXERCALCIFEROL | 201518 | 001 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 0.5MCG | No | No | 2016/09/09 | 2016/09/09 | RISING | Prescription |
DOXERCALCIFEROL | 201518 | 002 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 1MCG | No | No | 2016/09/09 | 2016/09/09 | RISING | Prescription |
DOXERCALCIFEROL | 201518 | 003 | ANDA | DOXERCALCIFEROL | CAPSULE;ORAL | 2.5MCG | No | No | 2016/09/09 | 2016/09/09 | RISING | Prescription |
DOXERCALCIFEROL | 208974 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 2MCG/ML (2MCG/ML) | No | No | 2017/05/24 | 2017/05/24 | AMNEAL | Discontinued |
DOXERCALCIFEROL | 208974 | 002 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2017/05/24 | 2017/05/24 | AMNEAL | Discontinued |
DOXERCALCIFEROL | 208975 | 001 | ANDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | No | No | 2017/05/24 | 2017/05/24 | AMNEAL | Discontinued |
DOXERCALCIFEROL | 208614 | 001 | NDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | Yes | No | 2018/07/24 | 2018/07/24 | HOSPIRA | Prescription |
DOXERCALCIFEROL | 208614 | 002 | NDA | DOXERCALCIFEROL | INJECTABLE;INJECTION | 10MCG/5ML (2MCG/ML) | Yes | No | 2018/07/24 | 2018/07/24 | HOSPIRA | Discontinued |